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Centers for Disease Control and Prevention (CDC). Use of combination measles, mumps, rubella, and varicella vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2010;59(RR-3):1–12.

2.

Centers for Disease Control and Prevention (CDC). Home. Vaccines for Children Program (VFC) Web site. http://www.cdc.gov/vaccines/programs/vfc/index.html. Updated April 24, 2014. Accessed March 2, 2016.

3.

Centers for Disease Control and Prevention (CDC). About VFC. Vaccines for Children Program (VFC) Web site. http://www.cdc.gov/vaccines/programs/vfc/about/index.html. Updated February 14, 2014. Accessed March 2, 2016.

4.

Centers for Disease Control and Prevention (CDC). VFC Detailed Questions and Answers for Parents. Vaccines for Children Program (VFC) Web site. http://www.cdc.gov/vaccines/programs/vfc/parents/qa-detailed.html. Updated February 19, 2013. Accessed March 2, 2016.

ProQuad is contraindicated in individuals with any of the following: history of anaphylactic reaction to neomycin or hypersensitivity to gelatin or any other component of the vaccine; primary or acquired immunodeficiency states; family history of congenital or hereditary immunodeficiency; immunosuppressive therapy; active untreated tuberculosis or febrile illness (>101.3°F or >38.5°C); or those who are pregnant. If vaccination of post-pubertal
females is undertaken, pregnancy should be avoided for 3 months following vaccination.

Administration of ProQuad (dose 1) to children 12 to 23 months old who have not been previously vaccinated against measles, mumps, rubella, or varicella, nor had a history of the wild-type infections, is associated with higher rates of fever and febrile seizures at 5 to 12 days after vaccination when compared to children vaccinated with dose 1 of both M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine Live) and VARIVAX® (Varicella Virus Vaccine Live) administered separately.

Use caution when administering ProQuad to children with: a history of cerebral injury or seizures or any other condition in which stress due to fever should be avoided; anaphylaxis or immediate hypersensitivity to eggs; contact hypersensitivity to neomycin; thrombocytopenia. Children with immediate hypersensitivity to eggs may be vaccinated with extreme caution; adequate treatment should be readily available should a reaction occur.

Advise vaccinees to avoid: close contact with high-risk individuals susceptible to varicella for up to 6 weeks following vaccination since transmission of varicella vaccine virus may occur between vaccinees and susceptible contacts; pregnancy for 3 months after vaccination; using salicylates for 6 weeks after vaccination. Defer vaccination for at least 3 months following blood or plasma transfusions, or administration of immune globulins (IG). The appropriate suggested interval between transfusion or IG administration and vaccination will vary with the type of transfusion or indication for, and dose of, IG.

Following administration of ProQuad, any immune globulin (IG), including VZIG, should not be given for 1 month thereafter unless its use outweighs the benefits of vaccination.

The most frequent vaccine-related adverse events reported in ≥5% of subjects vaccinated with ProQuad were: injection-site reactions (pain/tenderness/soreness, erythema, and swelling); fever; and irritability. Systemic vaccine-related adverse events that were reported at a significantly greater rate in recipients of ProQuad than in recipients of the component vaccines administered concomitantly were fever and measles-like rash. In children 12 to 23 months of age, the only vaccine-related injection-site adverse reaction that was more frequent among recipients of ProQuad than recipients of M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine, Live) and VARIVAX® (Varicella Virus Vaccine Live) was rash at the injection site (2.4% versus 1.6%, respectively).

A second dose, if needed, is usually administered at 4 to 6 years of age.

At least 1 month should elapse between a dose of a measles-containing vaccine such as M-M-R®II and a dose of ProQuad. At least 3 months should elapse between a dose of varicella-containing vaccine and ProQuad.

No clinical data are available regarding the development or worsening of thrombocytopenia in individuals vaccinated with ProQuad. Cases of thrombocytopenia have been reported after primary vaccination with measles vaccine; measles, mumps, rubella vaccine; after varicella vaccination; and following revaccination with measles vaccine or M-M-R®II.

The safety and efficacy of ProQuad for use after exposure to measles, mumps, rubella or varicella have not been established.

The safety and efficacy of ProQuad for use in children known to be infected with human immunodeficiency viruses have not been established.

In severely immunocompromised individuals who have been inadvertently vaccinated with measles containing vaccine, measles inclusion body encephalitis, pneumonitis and fatal outcome as a direct consequence of disseminated measles vaccine virus infection have been reported. In this population, disseminated mumps and rubella vaccine virus infection have also been reported.

Tuberculin testing should be administered anytime before, simultaneously with, or at least 4 to 6 weeks after ProQuad.

Each 0.5-mL dose of ProQuad is administered subcutaneously. The first dose is usually administered at 12 to 15 months of age but may be given anytime through 12 years of age.

If a second dose of measles, mumps, rubella, and varicella vaccine is needed, ProQuad may be used. This dose is usually administered at 4 to 6 years of age. At least 1 month should elapse between a dose of a measles-containing vaccine, such as M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine Live), and a dose of ProQuad. At least 3 months should elapse between a dose of varicella-containing vaccine and ProQuad.

Administration

TO MINIMIZE LOSS OF POTENCY, THE VACCINE SHOULD BE ADMINISTERED IMMEDIATELY AFTER RECONSTITUTION. IF NOT USED IMMEDIATELY, THE RECONSTITUTED VACCINE MAY BE STORED AT ROOM TEMPERATURE, PROTECTED FROM LIGHT, FOR UP TO 30 MINUTES. DISCARD RECONSTITUTED VACCINE IF IT IS NOT USED WITHIN 30 MINUTES.

Preparation for Administration

Withdraw the entire volume of the supplied diluent into a syringe. Use only the diluent supplied with the vaccine since it is free of preservatives and other anti-viral substances.

Inject the entire content of the syringe into the vial containing the powder. Gently agitate to dissolve completely.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Visually inspect the vaccine before and after reconstitution prior to administration. Before reconstitution, the lyophilized vaccine is a white to pale yellow compact crystalline plug. ProQuad, when reconstituted, is a clear pale yellow to light pink liquid.

Withdraw the entire amount of the reconstituted vaccine from the vial into the same syringe and inject the entire volume.

CAUTION: Preservatives, antiseptics, detergents, and other anti-viral substances may inactivate the vaccine. Use only sterile syringes that are free of preservatives, antiseptics, detergents, and other anti-viral substances for reconstitution and injection of ProQuad.

Method of Administration

Inject the vaccine subcutaneously into the outer aspect of the deltoid region of the upper arm or into the higher anterolateral area of the thigh.

Use With Other Vaccines

Use different injection sites to administer each vaccine if other vaccines are administered concomitantly. See Drug Interactions (7.5) in the fullPrescribing Information.

ProQuad is contraindicated in individuals with any of the following: history of anaphylactic reaction to neomycin or hypersensitivity to gelatin or any other component of the vaccine; primary or acquired immunodeficiency states; family history of congenital or hereditary immunodeficiency; immunosuppressive therapy; active untreated tuberculosis or febrile illness (>101.3°F or >38.5°C); or those who are pregnant. If vaccination of post-pubertal
females is undertaken, pregnancy should be avoided for 3 months following vaccination.

Administration of ProQuad (dose 1) to children 12 to 23 months old who have not been previously vaccinated against measles, mumps, rubella, or varicella, nor had a history of the wild-type infections, is associated with higher rates of fever and febrile seizures at 5 to 12 days after vaccination when compared to children vaccinated with dose 1 of both M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine Live) and VARIVAX® (Varicella Virus Vaccine Live) administered separately.

Use caution when administering ProQuad to children with: a history of cerebral injury or seizures or any other condition in which stress due to fever should be avoided; anaphylaxis or immediate hypersensitivity to eggs; contact hypersensitivity to neomycin; thrombocytopenia. Children with immediate hypersensitivity to eggs may be vaccinated with extreme caution; adequate treatment should be readily available should a reaction occur.

Advise vaccinees to avoid: close contact with high-risk individuals susceptible to varicella for up to 6 weeks following vaccination since transmission of varicella vaccine virus may occur between vaccinees and susceptible contacts; pregnancy for 3 months after vaccination; using salicylates for 6 weeks after vaccination. Defer vaccination for at least 3 months following blood or plasma transfusions, or administration of immune globulins (IG). The appropriate suggested interval between transfusion or IG administration and vaccination will vary with the type of transfusion or indication for, and dose of, IG.

Following administration of ProQuad, any immune globulin (IG), including VZIG, should not be given for 1 month thereafter unless its use outweighs the benefits of vaccination.

The most frequent vaccine-related adverse events reported in ≥5% of subjects vaccinated with ProQuad were: injection-site reactions (pain/tenderness/soreness, erythema, and swelling); fever; and irritability. Systemic vaccine-related adverse events that were reported at a significantly greater rate in recipients of ProQuad than in recipients of the component vaccines administered concomitantly were fever and measles-like rash. In children 12 to 23 months of age, the only vaccine-related injection-site adverse reaction that was more frequent among recipients of ProQuad than recipients of M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine, Live) and VARIVAX® (Varicella Virus Vaccine Live) was rash at the injection site (2.4% versus 1.6%, respectively).

A second dose, if needed, is usually administered at 4 to 6 years of age.

At least 1 month should elapse between a dose of a measles-containing vaccine such as M-M-R®II and a dose of ProQuad. At least 3 months should elapse between a dose of varicella-containing vaccine and ProQuad.

No clinical data are available regarding the development or worsening of thrombocytopenia in individuals vaccinated with ProQuad. Cases of thrombocytopenia have been reported after primary vaccination with measles vaccine; measles, mumps, rubella vaccine; after varicella vaccination; and following revaccination with measles vaccine or M-M-R®II.

The safety and efficacy of ProQuad for use after exposure to measles, mumps, rubella or varicella have not been established.

The safety and efficacy of ProQuad for use in children known to be infected with human immunodeficiency viruses have not been established.

In severely immunocompromised individuals who have been inadvertently vaccinated with measles containing vaccine, measles inclusion body encephalitis, pneumonitis and fatal outcome as a direct consequence of disseminated measles vaccine virus infection have been reported. In this population, disseminated mumps and rubella vaccine virus infection have also been reported.

Tuberculin testing should be administered anytime before, simultaneously with, or at least 4 to 6 weeks after ProQuad.